USFDA concludes inspection of NATCO’s Pharma Division, Kothur
Drug Approval

USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483

  • By IPP Bureau | June 20, 2025

NATCO Pharma Limited announced conclusion of US FDA Inspection at our Pharma Division located at Kothur, Hyderabad.

The US Food and Drug Administration (FDA) had conducted an inspection at our Pharma Division located in Kothur, Hyderabad, India, which was conducted from June 9th - June 19th, 2025.

On conclusion of the inspection, the company received seven observations in the Form-483. The company is confident it will address the observations within the stipulated timeline. Company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally.

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